Target 44-017-delisted

Target 44-017-delisted
SPL v16
SPL
SPL Set ID 5f66b48b-8196-4ad5-ab85-c6fd0fa66cbc
Route
ORAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-03-11 Until 2026-05-31
Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
Directions
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 Age (yr) Dose (mL)
children under 2 years  do not use 
children 2 to 5 years

do not use unless

directed by a doctor 
children 6 to 11 years  5 mL to 10 mL
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions?

Call 1-800-910-6874

Other Information
  • each 5 mL contains: sodium 4 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Principal Display Panel

NDC 11673-817-19

Compare to active

ingredient in Children's

Benadryl® Allergy*

dye-free

Children's

 allergy

 relief

diphenhydramine HCl, 12.5 mg

per 5 mL oral solution/antihistamine

alcohol and sugar free

for relief of:

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

up & up™

CHERRY

FLAVOR

AGES

6-11

YEARS

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Allergy.

50844 REV0123B01719

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2023 Target Brands, Inc.

Target 44-017
When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.

Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
Purpose

Antihistamine

Directions
  • do not take more than directed
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 Age (yr) Dose (mL)
children under 2 years  do not use 
children 2 to 5 years

do not use unless

directed by a doctor 
children 6 to 11 years  5 mL to 10 mL
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions?

Call 1-800-910-6874

Other Information (Other information)
  • each 5 mL contains: sodium 4 mg

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Principal Display Panel

NDC 11673-817-19

Compare to active

ingredient in Children's

Benadryl® Allergy*

dye-free

Children's

 allergy

 relief

diphenhydramine HCl, 12.5 mg

per 5 mL oral solution/antihistamine

alcohol and sugar free

for relief of:

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

up & up™

CHERRY

FLAVOR

AGES

6-11

YEARS

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Allergy.

50844 REV0123B01719

Distributed by Target Corporation

Minneapolis, MN 55403

TM & ©2023 Target Brands, Inc.

Target 44-017
When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.676932 · Updated: 2026-03-14T23:08:01.024401